510(k) K940219

TRIGEL- MULTIFUNCTION ELECTRODE by Physiometrix, Inc. — Product Code GEI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 12, 1994
Date Received: January 18, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Electrosurgical, Cutting & Coagulation & Accessories
Device Class: Class II
Regulation Number: 878.4400
Review Panel: SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Physiometrix, Inc.

K051874 — SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET (September 2, 2005)
K033999 — SEDLINE WITH FRONTAL PSI (February 6, 2004)
K020670 — MODEL 4310 PSARRAY2 EEG ELECTRODE (October 8, 2002)
K020671 — PSA4000 EEG MONITOR WITH FRONTAL PSI (October 4, 2002)
K001069 — MODEL 4000 EEG MONITOR WITH PSI (PSA4000) (June 30, 2000)
K001055 — MODEL 4300 PSARRAY EEG ELECTRODE SET (May 11, 2000)
K970942 — MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM (June 2, 1997)
K970694 — MODEL 1700, HYDRO PREP (May 14, 1997)
K962447 — EQUINOX DIGITAL EEG SYSTEM (December 12, 1996)
K962157 — MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM (November 25, 1996)

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K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+ (January 30, 2026)
K254220 — Reusable 3 Button Fingerswitch Wand (January 27, 2026)
K251435 — InbellaIgnite RF System (January 27, 2026)
K251254 — Ignite RF System (January 15, 2026)
K251996 — ENTire IRE System (January 14, 2026)
K251988 — Boston iFace (Boston iFace) (January 12, 2026)